the efemoral vascular scaffold system (evss) for the treatment of patients with symptomatic peripheral vascular disease from stenosis or occlusion of the femoropopliteal artery

Conditions: Peripheral Arterial Disease; Vascular Diseases; Stenosis; Femoropopliteal Stenosis

Summary: to evaluate the safety and performance of the evss in patients with symptomatic peripheral vascular disease from stenosis or occlusion of the femoropopliteal artery

the efemoral i study is a prospective, single-arm, open-labeled, multi-center, clinical investigation enrolling patients with arterial diameter of ≥5.5 mm and ≤6.5 mm and lesion length ≤90 mm receiving a single evss.

Eligibility criteria:
inclusion criteria: * symptomatic peripheral vascular occlusive disease (rutherford-becker clinical category 2-4) * patient with life expectancy \>36 months * females of childbearing potential must have negative pregnancy test * patient is able to provide informed consent * patient agrees to undergo all protocol-required follow-up examinations and requirements at the investigational site. * patient must be able to take antiplatelet and/or anticoagulant agents as prescribed * single de novo native disease segment of the superficial femoral artery (sfa) or p1 popliteal segment * reference vessel diameter ≥5.5 mm and ≤6.5 mm * target lesion length ≤90 mm * target lesion with ≥50% ds * inflow artery and popliteal artery free from flow-limiting lesion (ds \<50%) exclusion criteria: * hemoglobin \<9.0 g/dl * wbc \<3,000 cells/mm3 * platelet count \ 700,000 cells/mm3 * acute or chronic renal dysfunction with creatinine \>2.5 mg/dl (176 µmol/l) * severe liver impairment as defined by total bilirubin ≥3 mg/dl or two times increase over the normal level of sgot or sgpt * a known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, ticagrelor or sirolimus, or with contrast sensitivity for which the patient cannot be adequately pre-medicated * patient requires a planned procedure that would necessitate discontinuation of antiplatelet therapy * patient is unable to walk * patient has undergone a percutaneous vascular intervention \<30 days prior to the planned index procedure * patient is maintained on chronic hemodialysis * patient has uncontrolled diabetes mellitus (hba1c ≥7.0%). * patient has had a myocardial infarction within the previous 30 days of the planned index procedure * patient has had a stroke within the previous 30 days of the planned index procedure and/or has deficits from a prior stroke that limits the patient's ability to walk * patient has unstable angina defined as rest angina with ecg changes * patient has a local groin or acute systemic infection that has not been treated successfully or is currently under treatment * patient has acute thrombophlebitis, deep vein thrombosis or chronic venous insufficiency in either extremity * patient has other medical illnesses (e.g., cancer, congestive cardiomyopathy, etc.) that may cause the patient to be non-compliant with protocol requirements, confound the data interpretation or will prevent completion of all required follow up assessments through 36 months * patient is currently participating in an investigational drug, biologic, or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints * patient has ischemic or neuropathic ulcers on either foot * patient has undergone minor or major amputation of either lower extremity * patient is part of a vulnerable population who, in the judgment of the investigator, is unable to give informed consent * target extremity with an angiographically significant (\>50% ds) lesion located distal to the target lesion that requires treatment at the time of the index procedure or by a staged procedure * acute arterial ischemia of the target extremity * target extremity has been previously treated with open surgical revascularization (bypass or endarterectomy) * target vessel has been previously treated with stent, laser, atherectomy, surgical bypass, or endarterectomy * total occlusion (100% ds) of the ipsilateral inflow artery * angiographic evidence of thrombus in the target vessel * the target lesion requires treatment with a device other than percutaneous transluminal balloon angioplasty (pta) \[e.g., orbital atherectomy, directional atherectomy, excimer laser, rotational atherectomy, cryoplasty, etc.\] * target lesion is within or adjacent to an aneurysm * patient has angiographic evidence of thromboembolism or atheroembolism from treatment of an ipsilateral iliac lesion or from crossing or pre-dilating the target lesion * target lesion has moderate-to-severe calcification * target lesion with \> 30% residual stenosis following pre-dilatation

Keywords: peripheral artery disease bioresorbable